CE Marking for the TriGuard™ device, devised to minimize the risk of brain damage during TAVR, enables commencement of commercial use

Recent data demonstrates considerable reduction of new brain lesion volume during protected TAVR procedures performed with the TriGuard medical device

Keystone Heart, a leader in the development of cerebral protection devices for interventional cardiology and cardiac surgery procedures, announced today that its TriGuard™ Cerebral Protection Device has received CE Marking, enabling the company to commercially market the TriGuard in Europe and other territories. The CE marking recognises the conformity of the TriGuard device with the relevant directive of the European Community.

The CE marked TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during Transcatheter Aortic Valve Replacement (TAVR) and other cardiovascular procedures. It is the only system designed for placement via one of two femoral artery access ports. The TriGuard™ accommodates most anatomical variations of the aortic arch and uses a Nitinol® frame and mesh - flexible and atraumatic, yet robust and sturdy.

Cerebral function is the essence of quality of life. Its preservation throughout medical procedures is a key component to procedural success and patient care. Dr. Andreas Baumbach, Consultant Cardiologist at University Hospitals Bristol, UK and honorary Reader in Cardiology at the University of Bristol: "TriGuard is the most sophisticated cerebral embolic protection device currently available. The device has the potential to become a routine preventive measure in TAVI and other cardiovascular procedures associated with embolic lesions. European approval of the TriGuard device is an important advancement in patient care."

New scientific data presented at EuroPCR, demonstrated a significant reduction of new brain lesion volume during TAVR using TriGuard™ Cerebral Protection Device, compared with historical data on unprotected TAVR procedures. The clinical data shows that Maximum Total Lesion Volume was 95% smaller and Average Total Lesion Volume was 57% smaller when compared with historical references.

The medical community is witnessing heightened focus and scrutiny on cerebral injury concurrent with cardiovascular procedures - and research on possible preventative measures and devices to protect against brain injury has increased. Data from the PARTNER A study show nearly twice as many strokes in the TAVR group compared with the surgical Aortic Valve Replacement (AVR) group at 30 days, the majority of strokes being peri-procedural and within the first 2 days. In addition, newer "next generation" TAVR devices have so far have apparently failed to reduce TAVR-related risk of stroke.

These data affirm that protecting the brain is an important goal during TAVR and that TriGuardTM may provide such protection during TAVR and other cardiovascular procedures.

The TriGuard Device is not yet commercially available in the USA.

About KeystoneHeart
Keystone Heart Ltd is a medical device company developing and manufacturing cerebral protection devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain damage associated with cardiovascular procedures. The Company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other structural heart procedures. Novel devices are designed to help interventional cardiologists, electrophysiologists and cardiac surgeons to preserve brain reserve while performing these procedures.

Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. Clinical studies with the TriGuard™ Cerebral Protection Device (TAVR procedures) are currently ongoing in Europe, Canada and Brazil.

Keystone Heart collaborates with renowned interventional cardiologists, cardiac surgeons and neurologists.
The Company's management has extensive experience in the fields of interventional cardiology and medical devices.

Founded in 2004 and headquartered in Israel, Keystone Heart is funded by OrbiMed Advisors LLC and OrbiMed Israel Partners. The Company holds and maintains a comprehensive IP portfolio and is ISO certified.